遠隔転移のない頭頸部局所再発扁平上皮癌の第一選択治療におけるASP-1929光免疫療法とペンブロリズマブの併用に関する研究

基本情報

NCT ID

NCT06699212

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

412

治験依頼者名

Rakuten Medical, Inc.

概要

The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)